The investigators will conduct a 3-arm, pilot RCT where participants (N=30) will be randomized in a 1:1:1 design to 4 weeks of instructed bedtime MM practice at night (n=10) vs. uninstructed MM (n=10) vs. sleep hygiene education only (n=10). Aim 1 is to understand the feasibility and acceptability of the intervention and study procedures. Aim 2 is to explore patterns of within-group changes in sleep outcomes (i.e., insomnia severity and sleep quality). Patient-reported outcomes will be collected using a HIPAA-compliant electronic data management system (REDCap). Following informed consent, participants will receive links to REDCap surveys via email at Weeks 0, 4, 8, and 16. The investigators will also conduct a post-intervention interview at the end of Week 4 and an exit interview at Week 16. All participants will also receive a research kit with wearable devices and meet with our staff after they receive the kit for instructions. Data collected in the pilot RCT will help us to preliminarily identify tools for subjective measures and physiological signals to inform a future trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
30
All participants will access the a smartphone app, and the mindfulness meditation practice may involve techniques such as breathing exercise, imagery, body scan, and relaxation. The investigators will provide instructions for participants who are assigned to practice at bedtime.
The guided mindfulness meditation practice will also be based on the same app. The investigators will not provide instructions for participants, and they have complete freedom to use the app as real-world users.
Sleep hygiene education will be based on recognized, general, non-personalized sleep hygiene advice, for example, recommendations about bedtime routines and use of alcohol and caffeine, tips on creating a sleep-conducive bedroom environment.
Brigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGScreened-to-eligible ratio
The proportion of screened participants who were determined to be eligible for the study; calculated as the number of eligible participants divided by the total number of individuals screened.
Time frame: Week 0
Retention rate
Retention rate is defined as the percentage of participants who complete the entire follow-up period. Reasons for participant dropout will also be documented.
Time frame: Weeks 4, 8, and 16
Adherence to intervention protocol
In the intervention groups, a mindfulness meditation session ≥ 10 minutes will be considered as a completed session. Numbers of sessions completed during the four weeks will be recorded. Adherence to intervention protocol will be defined as those randomized to the intervention groups complete ≥ 70% of home practice.
Time frame: Week 4
Compliance with outcome assessment
Compliance with outcome assessment will be determined by the percentage of participants who complete ≥ 70% of questionnaires at each time point.
Time frame: Weeks 0, 4, 8, 16
Acceptability
At intervention end (week 4), a brief questionnaire will ask participants to rate (1=not at all to 5=very much) the enjoyableness, convenience, helpfulness, and overall satisfaction with the app-based mindfulness practice. Acceptability is assessed by self-report survey ratings, and a threshold of 80% ratings of 4 or higher will indicate acceptability.
Time frame: Week 4
Insomnia severity
Insomnia severity will be assessed by the Insomnia Severity Index (ISI), a brief instrument that assesses insomnia. Its reliability, validity, and sensitivity to treatment response have been documented in the general population and with patients with insomnia. The total score ranges from 0 to 28, and higher scores indicate more severe insomnia. This secondary/exploratory outcome will be summarized with simple descriptive statistics without formal efficacy testing.
Time frame: Weeks 0, 4, 8, 16
Sleep quality
Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI). PSQI is a subjective sleep assessment, which includes multiple sleep-related variables over the preceding month. The PSQI yields seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction. The global score ranges from 0 to 21, and higher scores suggest greater sleep disturbance. This secondary/exploratory outcome will be summarized with simple descriptive statistics without formal efficacy testing.
Time frame: Weeks 0, 4, 8, 16
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